The following is a cut and paste of Leslie's recent interview with ******:
Going for the FDA fast trackASX:IMU10 Jul 2024Imugene (ASX:IMU) CEO, Leslie Chong, reveals the encouraging progress their clinical-stage immuno-oncology company is making in trials for curing various types of cancer. The company's oncolytic virus targets cancer cells and has shown promising results for a patient with bowel cancer who remains in remission. Leslie notes that they've expanded the use of higher doses into a bile tract cancer trial, with positive anticipation for potential outcomes.A few thousand patients are affected by bile tract cancer with insufficient medication options available. Leslie mentions the opportunity this 'unmet need' provides for the company; through the use of their vaccine in a niche space, the company progresses forward with a fast track designation by FDA. A fast track saves the cost of creating a new drug in this space.Imugene is also testing a vaccine on other cancers, including lung, colon, breast and ovarian. If the vaccine continues to demonstrate effective results, the company expects to expedite its approval with the FDA for wider use. Leslie envisions significant growth and success for Imugene, as he believes the company's patient-focused approach will strike a chord with the market, enhancing its current value. Indeed, a patient with bowel cancer has entered remission, providing a glimmer of hope that this could potentially be a viable cure.Full unedited transcript below0:00Gene, a clinical stage immuno oncology company, has dosed its first patient in a trial targeting bile tract cancer sufferers. Joining me now is Imogene CEO Leslie Chong. Leslie, thanks so much for your time. Can you just tell us a little bit about what this is about? Absolutely. So we have an oncolytic virus that has an abhorrent hate for cancer. So it invades an infected0:26nurse. And in this case, we had seen some results as a meaningful result with a patient with bowel cancer. And that patient has been going on 530 some odd days now or more without any tumor recurrence. So it's currently in remission. And so that was only the mid dose in a phase one study. And now we've taken one of the higher doses in our dose escalation schema and have expanded that into a biotech cancer trial where we opened it, and now we have our first, um, patient in that expansion trial. And so we're we're quite excited about the and anticipating what this could mean. Tell us a little bit more about bile tract. I mean, how many people does it biotech cancer? Excuse me? How many people does it affect? What are the sort of long term implications? So it has, um, a few1:26thousand patients, um, and per regions to have been diagnosed. The more important aspect of that disease is that there's a it's a truly unmet need. There's not a lot of medication that actually, um, touches bio cancer. So that's why it's so meaningful. And in a drug developing company to find a niche or an unmet need that gives you, um, a fast track. So FDA has already designated that particular,1:59uh, region as a fast track designation. So if we were to turn this into a registration or to market study, we can get fast tracked by the FDA. Unmet need, smaller number of patients. That means, uh, just lower cash, um, to to burn in terms of creating a, a, a real drug in this particular space. And I understand that vaccine, um, has somewhat of a virus that can shrink other cancers, including colon, lung, breast and ovarian. Is that right? That's correct. So we have a phase one study with multiple solid tumors. So we have breast, Colangelo bladder, um, lung, you name it. Anything that's a solid cancer. We have uh, we have in our phase one dose escalating study. So phase ones are where you find just a dose and safety. And we to find a response2:58as early as in the phase one. That just means that your drug is quite active. And so we are excited about the expansion into, um, into the bio track cancer. And then also, uh, we'll be looking at another type of cancer to expand into, into a, into a small, um, expansion trial. So, Leslie, what are the next steps in terms of getting that FDA approval? So, uh, FDA loves things. That works just like patients do and just like we do. And so we're that's what we're trying to do. So within these ten patients, we have a certain number. If we have a certain number of patients that we can shrink the tumor, stabilize their tumor, or, uh, have long term, um, uh, tumor shrinkage and continue for those patients to continue to live. Then we can take that package into the FDA for a potential phase two, and then expediting that into a3:58phase three, uh, pivotal study is what we're trying to do.4:04Leslie, let's talk about what this could actually do for your company as well. We just saw a chart of a pretty good return for long term shareholders of imaging. I know that you can't control the market and CEOs don't talk about stock price moves. But I guess just in terms of value for Amgen, where do you see fair value. So uh, that's interesting that you say that. So, you know, um, imaging has been a our fundamentals are stronger than ever. We have 3 to 4 platform products that are wiping out data. Um, for me, I think it's all about patience as our North Star. If we do right by the patient and we've got an extraordinarily talented, experienced clinical developers who have done drug development specifically, specifically in this space. So I think where we're going to see our company is very successful in terms of, um, creating value for5:03patients as well as the stakeholders. Um, everyone so I think we need to focus on the patient so that we can get the value of the company increase even more. And can we also talk to you about your bowel cancer vaccine that was, um, newsworthy earlier in the year. How's that going? So that patient is still without is in remission. So that patient, uh, is going on, um, you know, I lose count because every day we, we celebrate this particular patient's, uh, resolve of his tumors. But I think he's at 530 some odd days, and we hope that, uh, so, doctors oncologist call it a cure once you've gone through the threshold of five years, it is quite rare for a bowel track cancer patients to live that long. And so this for this patient to almost, um, go beyond nearly two years threshold. I mean, it's, uh, it's6:03it's quite a feat. And so you don't like one of my, my CEO says you don't cure cancer by accident. So we're hoping that we are we are going towards that route.
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